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The main purpose of this study is to explore the pharmacokinetics, pharmacodynamics and safety after twice-daily dosing of tegoprazan tablets in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T1 | Experimental | Tegoprazan A mg or placebo |
|
| T2 | Experimental | Tegoprazan B mg or placebo |
|
| T3 | Experimental | Tegoprazan C mg or placebo |
|
| T4 | Experimental | Tegoprazan D mg or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegoprazan dose A or placebo | Drug | Tegoprazan A mg or placebo taken orally twice daily for 3 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Evaluation | Cmax of Tegoprazan and M1 | Up to 24 hours |
| Pharmacokinetics Evaluation | AUC0-t of Tegoprazan and M1 | Up to 24 hours |
| Pharmacokinetics Evaluation | AUC0-∞ of Tegoprazan and M1 | Up to 24 hours |
| Pharmacokinetics Evaluation | Tmax of Tegoprazan and M1 | Up to 24 hours |
| Pharmacokinetics Evaluation | t1/2β of Tegoprazan and M1 | Up to 24 hours |
| Pharmacokinetics Evaluation | CL/F of Tegoprazan | Up to 24 hours |
| Pharmacokinetics Evaluation | Vd/F of Tegoprazan | Up to 24 hours |
| Pharmacokinetics Evaluation | Css,max of Tegoprazan and M1 | Up to 24 hours |
| Pharmacokinetics Evaluation | Css,min of Tegoprazan and M1 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics Evaluation | Mean pH | 24 hours |
| Pharmacodynamics Evaluation | Median pH | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
Past medical history
Diagnostic test and electrocardiogram (ECG)
Allergy and drug abuse
Contraindicated drugs/foods
Blood donation and transfusion
Pregnancy, Breastfeeding, and Contraception
Others
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youngshin Keum, R.Ph, Pharm.D | Contact | +82-2-6477-0204 | ys.keum@inno-n.com | |
| Seokuee Kim, MD, PhD | Contact | +82-2-6477-0207 | seokuee.kim@inno-n.com |
| Name | Affiliation | Role |
|---|---|---|
| Jong Lyul Kim, MD, PhD | Inje University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Recruiting | Busan | 47392 | South Korea |
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| Tegoprazan dose B or placebo |
| Drug |
Tegoprazan B mg or placebo taken orally twice daily for 3 days. |
|
| Tegoprazan dose C or placebo | Drug | Tegoprazan C mg or placebo taken orally twice daily for 3 days. |
|
| Tegoprazan dose D or placebo | Drug | Tegoprazan D mg or placebo taken orally twice daily for 3 days. |
|
| Up to 24 hours |
| Pharmacokinetic Evaluation | Css,avg of Tegoprazan and M1 | Up to 24 hours |
| Pharmacokinetics Evaluation | AUC48-72h of Tegoprazan and M1 | Up to 24 hours |
| Pharmacokinetics Evaluation | Tmax,ss of Tegoprazan and M1 | Up to 24 hours |
| Pharmacokinetics Evaluation | t1/2β,ss of Tegoprazan and M1 | Up to 24 hours |
| Pharmacokinetics Evaluation | CLss/F of Tegoprazan | Up to 24 hours |
| Pharmacokinetics Evaluation | Vdss/F of Tegoprazan | Up to 24 hours |
| Pharmacodynamics Evaluation | TpH>4(%) | 24 hours |
| Pharmacodynamics Evaluation | TpH>6(%) | 24 hours |
| Pharmacodynamics Evaluation | Basal pH | 24 hours |
| Pharmacodynamics Evaluation | Δ TpH>4(%) | 24 hours |
| Pharmacodynamics Evaluation | Δ TpH>6(%) | 24 hours |
| Pharmacodynamics Evaluation | Δ mean pH | 24 hours |
| Pharmacodynamics Evaluation | Δ median pH | 24 hours |